A devious path bacterial barrier for providing an air/gas pathway to a sterile environment from an external environment, including a flat member lying within a plane and having spaced openings extending into the flat member and with one of the openings for communicating with the exterior environment and with the other of the openings for communicating with the sterile environment, a pathway extending between the openings and with the pathway extending within the flat member and along the plane of the flat member for interconnecting the openings and providing an air/gas pathway between the one opening of the flat member and the other opening, and the pathway including a plurality of bends along its length and with each bend providing an area to trap any bacteria introduced into the pathway from the exterior environment communicating with the one opening and with all the bacteria trapped at a distance along the pathway before the other opening communicating with the sterile environment.
The packaging system for a sterile hydrocephalus shunt provides access to the valves of the shunt for air testing of the opening and closing pressures of the valves without compromising the sterility of the shunt. The packaging system comprises two nested plastic packs positioned around the shunt with access to the valves of the shunt being provided by an air feedthrough connector assembly which includes a bacteriostatic filter to maintain the contents of the packaging system sterile against contamination by the air used in the pressure testing of the valves. The bacteriostatic filter is impervious to bacterial contaminants but is pervious to air or gaseous sterilizing agents which may be passed therethrough.
A gas-permeable, pathogen-resistant seal for sealing packages containing medical products is described. The seal comprises a labyrinthine passage, preferably formed in two dimensions, through which bacteria cannot pass. The seal functions to block the passage of bacteria without an additional bacteria blocking material. A method for making the subject seal using heat sealing techniques is also described.
Openings are provided in the walls of a sterilization container, particularly one for surgical instruments, to allow for the introduction of a sterilant gas, and a filter element is provided internally of these openings. To prevent external objects from entering the openings in the surface and penetrating the filter element, a relatively stiff perforate sheet, preferably formed of metal, is placed between the surface of the container and the filter element, the perforations in the sheet being offset from the openings in the container wall.
Valves useful for pressure relief/ventilation/vacuum or pressure retention, particularly in packaging containers, are disclosed. The present valves include a first member which is substantially rigid, includes an outer sealing region and a raised section having at least one hole therethrough; and a second member which is substantially elastic, is in close proximity to, preferably in contact with, the raised section of the first member and is sealingly secured the first member at the outer sealing region. The second member includes at least one through hole located outwardly or outboard of the raised section of the first section and inwardly of the outer sealing region of the first member. The elastic member may be moved away from the raised section to equalize gas pressures between a container and the environment outside the container or is urged into more intimate contact with the raised section to prevent gas flow into or out of the container. The present valves are effective and reliable for repeated and/or long term use.
A liquid sterilizing system (A) defines a basin (10) in which a container (B) is removably disposed. The liquid sterilizing system selectively pumps sterile rinse liquids from a supply (24) and liquid sterilant solutions from a supply (70) into the basin filling the basin and the container. The container includes a lower shell having a bottom wall (34) that defines an aperture (32) for receiving sterilant and sterile rinse liquids. A nozzle plate (44) is mounted close to but spaced from the shell bottom wall to define a tortuous liquid distribution path (40) between the inlet aperture and nozzle plate apertures (90). A barrier (96) divides the liquid receiving portion and a drain portion of the liquid distribution path between the shell bottom surface and the nozzle plate. A cover (80) has a downward depending peripheral wall (82) which is offset from the shell peripheral wall (86) by the spacers (88) to define a tortuous vent path (48) therethrough. The container is lifted out by handles (100) which enable the container to be removed without disturbing the transparent cover, hence, without disturbing the sterile condition of the items within the container. In this manner, the sterilized items can be inventoried and maintained sterilized in the container for an extended duration.